FDA.reportPublic FDA data

Application 206039

Type
ANDA
Sponsor
EXELA PHARMA SCS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MAGNESIUM SULFATEMAGNESIUM SULFATESOLUTION;INTRAMUSCULAR, INTRAVENOUS5GM/10ML (500MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51754-1000Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEExela Pharma Sciences, LLCANDACurrent
70518-1607Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEREMEDYREPACK INC.ANDACurrent